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海思科(002653.SZ):1类创新药安瑞克芬注射液新适应症获批
Ge Long Hui A P P· 2025-09-15 11:40
Core Viewpoint - The company has received approval from the National Medical Products Administration for its innovative drug, HSK21542, which is expected to provide better options for patients suffering from itching [1] Company Summary - HSK21542, marketed as Anruikefen Injection (brand name: Sishujing), is a highly selective peripheral kappa opioid receptor agonist developed independently by the company [1] - Clinical research indicates that HSK21542 significantly alleviates itching, with both primary and secondary efficacy indicators showing substantial improvement over the placebo group [1] - The safety profile of HSK21542 injection is reported to be good and controllable [1] Industry Summary - The newly approved indication for HSK21542 will be included in the priority review and approval process in July 2024, highlighting the drug's potential impact on the market [1] - The approval of HSK21542 is expected to enhance treatment options for patients, indicating a positive development in the pharmaceutical industry focused on innovative therapies [1]
海思科:安瑞克芬注射液新适应症获批
Zheng Quan Shi Bao Wang· 2025-09-15 11:28
Core Viewpoint - The company Haishi Ke (002653) has received a Class 1 innovative drug registration certificate from the National Medical Products Administration for its injection drug Anruikefen (brand name: Sishujing, R&D code: HSK21542), which is indicated for the treatment of moderate to severe itching associated with chronic kidney disease in adult patients undergoing maintenance hemodialysis [1]. Group 1 - The drug Anruikefen has been approved for a new indication related to chronic kidney disease [1]. - The approval highlights the company's ongoing commitment to developing innovative treatments for patients with specific medical needs [1].
海思科安瑞克芬注射液新适应症获批
Zhi Tong Cai Jing· 2025-09-15 11:20
Core Viewpoint - The company has received a Class 1 innovative drug registration certificate from the National Medical Products Administration for Anruikefen injection (brand name: Sishujing, R&D code: HSK21542), with a new indication for treating moderate to severe itching related to chronic kidney disease in adult patients undergoing maintenance hemodialysis [1] Group 1 - The drug Anruikefen is now approved for a new indication, expanding its potential market [1] - The approval highlights the company's commitment to developing innovative treatments for chronic conditions [1] - This development may enhance the company's competitive position in the pharmaceutical industry [1]